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ABBOTT's TEMAFLOXACIN IS BEING STUDIED FOR CHRONIC BRONCHITIS

Executive Summary

ABBOTT's TEMAFLOXACIN IS BEING STUDIED FOR CHRONIC BRONCHITIS bacterial exacerbation and male non-gonococcal urethritis, according to studies scheduled for delivery at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Houston, Texas on Sept 17-20. Temafloxacin, a quinolone antibiotic currently in Phase III trials has demonstrated activity against a variety of respiratory pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Haemophilus influenzae and Legionella pneumoniae. According to one study to be presented at ICAAC, temafloxacin was four to ten times more active than the leading marketed quinolone ciprofloxacin and three to 10 times more active than oflaxacin against S. pneumoniae, S. pyogenes, and S. aureus. Temafloxacin had equivalent activity to ciprofloxacin and oflaxacin against the other pathogens. In three prospective double-blind randomized trials studying temafloxacin for the treatment of chronic bronchitis, 204 patients received oral doses of either 300 mg and 600 mg twice daily for 10 days. Clinical cure or improvement was noted in 96% of the 193 evaluable patients and bacterial eradication in 94% of 189 patients with infections. Mild to moderate adverse events occurred in 8.8% of patients. Another study in 102 males with non-gonococcal urethritis found that temafloxacin demonstrated significant efficacy in eradicating the disease. Patients were treated with 200 mg or 400 mg of temafloxacin twice daily for seven days. Urethral cultures were taken pre-treatment, days 5-7 during treatment, 5-9 days post-treatment and 21-28 days post-treatment. The clinical cure rate was 96.8% for the 200 mg dose and 100% for the 400 mg dose five to nine days post-treatment. On days 21-28 post-treatment, the cure rate was 92.6% for the 200 mg dose and 100% for the 400 mg dose. Adverse events were mild to moderate. Abbott will present studies on at least 15 other antibiotics it has in development including four altromycins and new macrolide antibiotics. Lilly will make presentations at the ICAAC meting on three antibiotics currently in clinical development and approximately 12 others in earlier stages of development. Clinical trials are underway for daptomycin, dirithromycin and cilofungin. Among the antibiotics in early preclinical development, Lilly has a new thiopeptide antibiotic, a new polyether antibiotic, and a new oral carbacephalosporin derivative.
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